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Align Technology Announces Record Fourth Quarter and Fiscal 2020 Financial Results

February 3, 2021 4:00 PM

TEMPE, Ariz., Feb. 03, 2021 (GLOBE NEWSWIRE) -- Align Technology, Inc. (Nasdaq: ALGN) today reported financial results for the fourth quarter ("Q4'20") and year ended December 31, 2020. Q4'20 total revenues were $834.5 million, up 28.4% year-over-year. Q4'20 Clear Aligner revenues were $700.7 million, up 28.9% year-over-year and Q4'20 Imaging Systems and CAD/CAM Services revenues were $133.8 million, up 26.0% year-over-year. Q4'20 Clear Aligner volume was 568.0 thousand cases, up 37.3% year-over-year. For the Americas and International regions, Q4'20 Clear Aligner volume was up 34.1% and up 41.1% year-over-year, respectively. Q4'20 Clear Aligner volume for teenage patients was 160.9 thousand cases, up 38.7% year-over-year. Q4'20 operating income of $213.2 million was up 41.0% year-over-year, resulting in an operating margin of 25.5%. Q4'20 GAAP net income was $159.0 million, or $2.00 per diluted share. On a non-GAAP basis, Q4'20 net income was $207.7 million, or $2.61 per diluted share.

Commenting on Align's Q4'20 and 2020 results, Align Technology President and CEO Joe Hogan said, “Our fourth quarter was a strong finish to the year -- with record revenues and volumes from both Invisalign aligners and iTero scanners, as well as increased gross margins, operating margins, EPS, and cash flow. Our Q4 performance was driven by strong year-over-year growth across customer channels and regions and continued momentum sequentially. Q4 reflects increased Invisalign adoption from both adults and teenagers, which were up 36.7% and 38.7% year-over-year, respectively. Our Teen and Mom-focused consumer campaign generated a +77% year-over-year increase in unique visitors to our website and a 76% increase in leads generated. In addition, Invisalign social media influencers like Charli D' Amelio, Marsai Martin, Christina Milian, Tisha Campbell-Martin, Rachel Zoe, Tiffany Ma, and Tahj Mowry continued to deliver exciting new content and increased engagement for the Invisalign brand with consumers and among their millions of followers.”

For 2020, total revenues were a record $2.5 billion, up 2.7% year-over-year. Record 2020 Clear Aligner revenues were $2.1 billion, up 3.7% year-over-year and record Clear Aligner volume was 1.6 million cases, up 7.0% year-over-year. 2020 Imaging Systems and CAD/CAM Services revenues were $370.5 million, down 2.8% year-over-year. 2020 Invisalign cases for teenage patients were 498.2 thousand, up 11.5% year-over-year. 2020 net income was $1,775.9 million, or $22.41 per diluted share. On a non-GAAP basis, 2020 net income was $415.9 million, or $5.25 per diluted share.

Continued Hogan, “2020 was a year unlike any other that we have experienced. The COVID-19 pandemic and its impact have been life-changing – marked by loss and separation, recovery and renewal, record highs and lows, and significant milestones and accomplishments even in a time of huge disruption. Despite the swift onset of the pandemic and uncertainty throughout 2020, we didn’t halt our plans or change our strategy for continued growth. We completed the acquisition and integration of exocad; accelerated our investments in marketing to create Invisalign brand awareness and drive consumer demand for our doctors’ offices; accelerated new technology to market with virtual tools that enabled our doctors to stay connected with their patients; provided PPE to those in need; and supported doctors and their teams with online education and digital forums that went beyond products to help them navigate the uncertainties of the pandemic. As a result of our continued strategic focus and investments, we exited the year stronger than we started and 2021 is off to a great start.”

Financial Summary - Fourth Quarter Fiscal 2020

Q4'20Q3'20Q4'19
Invisalign Case Shipments 1 567,950 496,065 413,715
GAAP
Net Revenues$834.5M$734.1M$649.8M
Clear Aligner 2$700.7M$620.8M$543.6M
Imaging Systems & CAD/CAM Services$133.8M$113.4M$106.2M
Net Income$159.0M$139.4M$121.3M
Diluted EPS$2.00$1.76$1.53
Non-GAAP
Net Income$207.7M$177.9M$139.4M
Diluted EPS$2.61$2.25$1.76

Financial Summary - Fiscal 2020

2020 2019
Invisalign Case Shipments 1 1,645,335 1,525,415
GAAP
Net Revenues$2,471.9M$2,406.8M
Clear Aligner 2$2,101.5M$2,025.8M
Imaging Systems & CAD/CAM Services$370.5M$381.0M
Net Income$1,775.9M$442.8M
Diluted EPS$22.41$5.53
Non-GAAP
Net Income$415.9M$478.3M
Diluted EPS$5.25$5.97

1Invisalign shipments do not include SmileDirectClub ("SDC ") aligners. 2 Clear Aligner revenues include Invisalign clear aligners and SDC aligners. The supply agreement with SDC terminated on December 31, 2019, and was not renewed.

As of December 31, 2020, Align had $960.8 million in cash and cash equivalents and marketable securities, short-term, compared to $868.6 million as of December 31, 2019. Additionally, we have $100.0 million remaining available for repurchase of our common stock under our May 2018 Repurchase Program.

2020 Announcement Highlights:

Product

Align Web Cast and Conference CallAlign will host a conference call today, February 3, 2021, at 4:30 p.m. ET, 2:30 p.m. MT, to review its fourth quarter and full-year 2020 results, discuss future operating trends and the business outlook. The conference call will also be webcast live via the Internet. To access the webcast, go to the "Events & Presentations" section under Company Information on Align's Investor Relations web site at http://investor.aligntech.com. To access the conference call, please dial 201-689-8261. An archived audio webcast will be available beginning approximately one hour after the call's conclusion and will remain available for approximately one month. Additionally, a telephonic replay of the call can be accessed by dialing 877-660-6853 with conference number 13714292 followed by #. For international callers, please dial 201-612-7415 and use the same conference number referenced above. The telephonic replay will be available through 5:30 p.m. ET on February 17, 2021.

About Non-GAAP Financial MeasuresTo supplement our condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States ("GAAP"), we may provide investors with certain non-GAAP financial measures for gross profit, gross margin, operating expenses, income from operations, operating margin, interest income and other income (expense), net, net income before provision for (benefit from) income taxes, effective tax rate, net income and diluted net income per share, which exclude certain items that may not be indicative of our fundamental operating performance including discrete cash and non-cash charges or gains that are included in the most directly comparable GAAP measure. Non-GAAP measures will exclude the effects of stock-based compensation, amortization of acquired intangibles, non-cash deferred tax assets and associated amortization related to the intra-entity transfer of non-inventory assets, acquisition-related costs, impairments and other (gains) charges, and litigation settlement gains, and, if applicable, any associated tax impacts.

We use non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding our recurring core operating performance. We believe that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. These non-GAAP financial measures also facilitate management's internal evaluation of period-to-period comparisons. We believe these non-GAAP financial measures are useful to investors both because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they will be provided to and used by our institutional investors and the analyst community to help them analyze the performance of our business.

There are limitations to using non-GAAP financial measures, though, because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. The non-GAAP financial measures are limited in value because they exclude certain items that may have a material impact upon our reported financial results. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management about which charges are excluded from the non-GAAP financial measures. We compensate for these limitations by analyzing current and future results on a GAAP as well as a non-GAAP basis and also by providing GAAP measures in our public disclosures. The presentation of non-GAAP financial information is meant to be considered in addition to, not as a substitute for or in isolation from, the directly comparable financial measures prepared in accordance with GAAP. We urge investors to review the reconciliation of our GAAP financial measures to the comparable Non-GAAP financial measures included in this presentation and not to rely on any single financial measure to evaluate our business. For more information on these non-GAAP financial measures, please see the table captioned "Unaudited GAAP to Non-GAAP Reconciliation."

About Align Technology, Inc.Align Technology designs and manufactures the Invisalign® system, the most advanced clear aligner system in the world, iTero® intraoral scanners and services, and exocad CAD/CAM software. Align has helped treat over 9.6 million patients with the Invisalign system and is driving the evolution in digital dentistry with the iTero intraoral scanner and exocad CAD/CAM software − modernizing today's practices by enabling enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Forward-Looking StatementsThis news release contains forward-looking statements, including quotations from management regarding business and product momentum, the COVID-19 pandemic and its impact on our business and results of operations, our expectations for digital adoption in dentistry and the potential impact of our products in the transition, our expectations for our marketing activities, and our expectations for our new products, features, and accessories and their availability. Forward-looking statements contained in this news release relating to expectations about future events or results are based upon information available to Align as of the date hereof. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties, and assumptions that are difficult to predict. As a result, actual results may differ materially and adversely from those expressed in any forward-looking statement.

Factors that might cause such a difference include, but are not limited to:

The foregoing and other risks are detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including, but not limited to, our Annual Report on Form 10-K for the year ended December 31, 2019, which was filed with the Securities and Exchange Commission (SEC) on February 28, 2020, and its latest Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the SEC on October 30, 2020. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Three Months EndedDecember 31, Year EndedDecember 31,
2020 2019 2020 2019
Net revenues $834,520 $649,787 $2,471,941 $2,406,796
Cost of net revenues 224,057 177,829 708,706 662,899
Gross profit 610,463 471,958 1,763,235 1,743,897
Operating expenses:
Selling, general and administrative 348,392 279,481 1,200,757 1,072,053
Research and development 48,887 41,327 175,307 157,361
Impairments and other (gains) charges - - - 22,990
Litigation settlement gain - - - (51,000)
Total operating expenses 397,279 320,808 1,376,064 1,201,404
Income from operations 213,184 151,150 387,171 542,493
Interest income and other income (expense), net:
Interest income 337 2,906 3,125 12,482
Other income (expense), net 1,021 1,741 (11,347) 7,676
Total interest income and other income (expense), net 1,358 4,647 (8,222) 20,158
Net income before provision for (benefit from) income taxes and equity in losses of investee 214,542 155,797 378,949 562,651
Provision for (benefit from) income taxes 55,554 34,535 (1,396,939) 112,347
Equity in losses of investee, net of tax - - - 7,528
Net income $158,988 $121,262 $1,775,888 $442,776
Net income per share:
Basic $2.02 $1.54 $22.55 $5.57
Diluted $2.00 $1.53 $22.41 $5.53
Shares used in computing net income per share:
Basic 78,853 78,578 78,760 79,424
Diluted 79,505 79,137 79,230 80,100

ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
December 31,2020 December 31,2019
ASSETS
Current assets:
Cash and cash equivalents $960,843 $550,425
Marketable securities, short-term - 318,202
Accounts receivable, net 657,704 550,291
Inventories 139,237 112,051
Prepaid expenses and other current assets 91,754 102,450
Total current assets 1,849,538 1,633,419
Property, plant and equipment, net 734,721 631,730
Operating lease right-of-use assets, net 82,553 56,244
Goodwill 444,817 63,924
Intangible assets, net 130,072 11,768
Deferred tax assets 1,552,831 64,007
Other assets 35,151 39,610
Total assets $4,829,683 $2,500,702
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $142,132 $87,250
Accrued liabilities 405,582 319,958
Deferred revenues 777,887 563,762
Total current liabilities 1,325,601 970,970
Income tax payable 105,748 102,794
Operating lease liabilities 64,445 43,463
Other long-term liabilities 100,024 37,306
Total liabilities 1,595,818 1,154,533
Total stockholders' equity 3,233,865 1,346,169
Total liabilities and stockholders' equity $4,829,683 $2,500,702

ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year EndedDecember 31,
2020 2019
CASH FLOWS FROM OPERATING ACTIVITIES
Net cash provided by operating activities $662,174 $747,270
CASH FLOWS FROM INVESTING ACTIVITIES
Net cash used in investing activities (231,506) (350,444)
CASH FLOWS FROM FINANCING ACTIVITIES
Net cash used in financing activities (30,808) (485,540)
Effect of foreign exchange rate changes on cash, cash equivalents, and restricted cash 10,480 2,282
Net increase (decrease) in cash, cash equivalents, and restricted cash 410,340 (86,432)
Cash, cash equivalents, and restricted cash at beginning of the period 551,134 637,566
Cash, cash equivalents, and restricted cash at end of the period $961,474 $551,134

ALIGN TECHNOLOGY, INC.
INVISALIGN BUSINESS METRICS*
Q1 Q2 Q3 Q4 Fiscal Q1 Q2 Q3 Q4 Fiscal
2019 2019 2019 2019 2019 2020 2020 2020 2020 2020
Invisalign Average Selling Price (ASP):
Worldwide ASP $1,245 $1,230 $1,260 $1,240 $1,245 $1,255 $1,255 $1,180 $1,165 $1,200
International ASP $1,330 $1,305 $1,330 $1,300 $1,315 $1,340 $1,285 $1,240 $1,255 $1,270
Invisalign Cases Shipped by Geography:
Americas 202,935 211,360 215,355 225,925 855,575 213,505 100,995 268,970 302,995 886,465
International 146,260 165,785 170,005 187,790 669,840 145,935 120,885 227,095 264,955 758,870
Total Cases Shipped 349,195 377,145 385,360 413,715 1,525,415 359,440 221,880 496,065 567,950 1,645,335
YoY % growth 28.3% 24.6% 20.7% 23.9% 24.2% 2.9% -41.2% 28.7% 37.3% 7.9%
QoQ % growth 4.6% 8.0% 2.2% 7.4% -13.1% -38.3% 123.6% 14.5%
Number of Invisalign Doctors Cases Were Shipped To:
Americas 30,200 31,445 31,975 33,130 47,130 32,315 22,165 34,625 38,165 49,615
International 26,510 28,970 30,980 33,720 48,650 28,535 25,945 35,380 38,585 52,445
Total Doctors Cases Shipped To 56,710 60,415 62,955 66,850 95,780 60,850 48,110 70,005 76,750 102,060
Invisalign Doctor Utilization Rates**:
North America 7.0 7.0 7.0 7.2 19.4 6.9 4.8 8.4 8.7 19.8
North American Orthodontists 18.3 18.9 19.1 19.3 65.0 18.9 11.0 24.1 25.0 67.3
North American GP Dentists 3.6 3.6 3.5 3.8 9.5 3.6 2.5 4.2 4.5 9.6
International 5.5 5.7 5.5 5.6 13.8 5.1 4.7 6.4 6.9 14.5
Total Utilization Rates 6.2 6.2 6.1 6.2 15.9 5.9 4.6 7.1 7.4 16.1
Number of Invisalign Doctors Trained:
Americas 1,840 3,070 2,760 2,095 9,765 2,035 1,140 3,350 2,550 9,075
International 2,410 3,520 3,135 3,445 12,510 2,600 2,350 3,175 3,900 12,025
Total Doctors Trained Worldwide 4,250 6,590 5,895 5,540 22,275 4,635 3,490 6,525 6,450 21,100
Total to Date Worldwide 156,205 162,795 168,690 174,230 174,230 178,865 182,355 188,880 195,330 195,330
* Invisalign business metrics exclude SmileDirectClub aligners.
** # of cases shipped / # of doctors to whom cases were shipped. LATAM utilization rate is not separately disclosed, but included in the total utilization rates.
ALIGN TECHNOLOGY, INC.
STOCK-BASED COMPENSATION
(in thousands)
Q1 Q2 Q3 Q4 Fiscal Q1 Q2 Q3 Q4 Fiscal
2019 2019 2019 2019 2019 2020 2020 2020 2020 2020
Stock-based Compensation (SBC)
SBC included in Gross Profit $1,112 $1,278 $1,354 $1,410 $5,154 $1,347 $891 $1,247 $1,234 $4,719
SBC included in Operating Expenses 19,932 21,189 22,822 19,087 83,030 21,580 24,116 23,982 24,030 93,708
Total SBC $21,044 $22,467 $24,176 $20,497 $88,184 $22,927 $25,007 $25,229 $25,264 $98,427

ALIGN TECHNOLOGY, INC.
UNAUDITED GAAP TO NON-GAAP RECONCILIATION
(in thousands except per share data)
Three Months EndedDecember 31, Year EndedDecember 31,
2020 2019 2020 2019
GAAP gross profit $610,463 $471,958 $1,763,235 $1,743,897
Stock-based compensation 1,234 1,410 4,719 5,154
Amortization of intangibles (1) 2,175 - 6,525 -
Non-GAAP gross profit $613,872 $473,368 $1,774,479 $1,749,051
GAAP gross margin 73.2% 72.6% 71.3% 72.5%
Non-GAAP gross margin 73.6% 72.8% 71.8% 72.7%
GAAP operating expenses $397,279 $320,808 $1,376,064 $1,201,404
Stock-based compensation (24,030) (19,087) (93,708) (83,030)
Amortization of intangibles (1) (887) - (3,062) -
Acquisition related costs (2) (62) - (7,683) -
Impairments and other (gains) charges (3) - - - (22,990)
Litigation settlement gain (4) - - - 51,000
Non-GAAP operating expenses $372,300 $301,721 $1,271,611 $1,146,384
GAAP income from operations $213,184 $151,150 $387,171 $542,493
Stock-based compensation 25,264 20,497 98,427 88,184
Amortization of intangibles (1) 3,062 - 9,587 -
Acquisition related costs (2) 62 - 7,683 -
Impairments and other (gains) charges (3) - - - 22,990
Litigation settlement gain (4) - - - (51,000)
Non-GAAP income from operations $241,572 $171,647 $502,868 $602,667
GAAP operating margin 25.5% 23.3% 15.7% 22.5%
Non-GAAP operating margin 28.9% 26.4% 20.3% 25.0%
GAAP interest income and other income (expense), net $1,358 $4,647 $(8,222) $20,158
Acquisition related costs (2) - - 10,187 -
Non-GAAP interest income and other income (expense), net $1,358 $4,647 $1,965 $20,158
GAAP net income before provision for (benefit from) income taxes and equity in losses of investee $214,542 $155,797 $378,949 $562,651
Stock-based compensation 25,264 20,497 98,427 88,184
Amortization of intangibles (1) 3,062 - 9,587 -
Acquisition related costs (2) 62 - 17,870 -
Impairments and other (gains) charges (3) - - - 22,990
Litigation settlement gain (4) - - - (51,000)
Non-GAAP net income before provision for (benefit from) income taxes and equity in losses of investee $242,930 $176,294 $504,833 $622,825
GAAP provision for (benefit from) income taxes $55,554 $34,535 $(1,396,939) $112,347
Tax impact on non-GAAP adjustments 2,635 2,390 23,566 24,635
Tax related non-GAAP items (5) (22,984) - 1,462,302 -
Non-GAAP provision for (benefit from) income taxes $35,205 $36,925 $88,929 $136,982
GAAP effective tax rate 25.9% 22.2% (368.6)% 20.0%
Non-GAAP effective tax rate 14.5% 20.9% 17.6% 22.0%
GAAP net income $158,988 $121,262 $1,775,888 $442,776
Stock-based compensation 25,264 20,497 98,427 88,184
Amortization of intangibles (1) 3,062 - 9,587 -
Acquisition related costs (2) 62 - 17,870 -
Impairments and other (gains) charges (3) - - - 22,990
Litigation settlement gain (4) - - - (51,000)
Tax impact on non-GAAP adjustments (2,635) (2,390) (23,566) (24,635)
Tax related non-GAAP items (5) 22,984 - (1,462,302) -
Non-GAAP net income $207,725 $139,369 $415,904 $478,315
GAAP diluted net income per share $2.00 $1.53 $22.41 $5.53
Non-GAAP diluted net income per share $2.61 $1.76 $5.25 $5.97
Shares used in computing diluted net income per share 79,505 79,137 79,230 80,100
Notes:
(1) During the three months and year ended December 31, 2020, we recorded amortization of intangible assets related to our Q2'20 exocad acquisition.
(2) During the year ended December 31, 2020, we recorded certain incremental expenses related to our Q2'20 exocad acquisition including third party advisory, legal, tax, accounting, banking, valuation, and other professional or consulting fees and foreign exchange losses related to a forward contract for the purchase commitment. Acquisition costs for the three months ended December 31, 2020 relate to professional fees.
(3) During the year ended December 31, 2019, we recorded a net impairment charge of $23.0 million consisting of impairments and other charges as a result of closing our Invisalign stores due to the arbitrator's decision regarding SDC including operating lease right-of-use asset impairments, store leasehold improvement and fixed asset impairments and employee severance and other charges offset by a gain from the negotiation of early termination of our Invisalign store leases.
(4) During the year ended December 31, 2019, we recorded a $51.0 million gain from the settlement of the Straumann litigation.
(5) During the year ended December 31, 2020, we recorded a one-time net tax benefit for the deferred tax asset and certain costs associated with the intra-entity transfer in the three months ended March 31, 2020 of certain intellectual property rights and assets to our Swiss subsidiary and related tax impact from the amortization of the transferred intangibles assets. For the three months ended December 31, 2020, we recorded amortization of the benefit from the transferred intangibles assets.
Refer to "About Non-GAAP Financial Measures" section of press release.

Align TechnologyZeno Group
Madelyn HomickSarah Johnson
(408) 470-1180(828) 551-4201
[email protected][email protected]

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Source: Align Technology, Inc.

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